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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Fairmont Dairy LLC 19-Mar-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896


 


 

WARNING LETTER
NWE-11-07W

VIA FEDERAL EXPRESS

March 19, 2007

David Tucker Purchase, Co-Owner
Fairmont Dairy LLC
224 Echo Hill Road
Craftsbury, VT 05826

Dear Mr. Purchase:

An investigation of your dairy operation located at 783 South Albany Road, Craftsbury, VT conducted by a representative of the U.S. Food and Drug Administration (FDA) on December 5, 2006 confirmed that you offered two animals for sale for slaughter as food that were adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. 342(a)(2)(C)(ii) and 402(a)(4) [21 U.S.C. § 342 (a)(4)] of the Federal Food Drug, and Cosmetic Act (the Act). The investigation also revealed that you caused the new animal drugs penicillin G procaine and flunixin meglumine injection to be unsafe under Section 512(a) [21 U.S.C. § 360b] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

On or about August 3, 2006 a dairy cow from your farm identified with Back Tag 13JX2991 and Farm Tag 7109 was picked up and transported to cattle dealer [redacted]. The cow was sold on August 4, 2006 to [redacted] or slaughter as food. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS)analysis of tissue samples collected from that animal on August 4, 2006 identified the presence of 0.22 parts per million (ppm) of penicillin in the kidney tissue of the cow. A tolerance of 0.05 ppm has been established for residues of penicillin in the edible tissues of cattle as codified in the Title 21, Code of Federal Regulations, section 556.510 (21 C.F.R. 556.510).The presence of this drug in this amount in edible tissues from this animal causes the food to be adulterated within the meaning of 402(a)(2)(C)(ii)[21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.

In addition, on or about October 16, 2006, a dairy cow from your farm identified with Back Tag 16KE1807 and Farm Tag 6785 was picked up and transported to cattle dealer [redacted]. The cow was sold on October 16, 2006, [redacted] for slaughter as food. The USDA/FSIS analysis of tissue samples collected from this animal on October 17, 2006, identified the presence of 0.234 ppm of flunixin in the liver tissue of this cow. A tolerance of 0.125 ppm has been established for residues of flunixin in the liver of cattle as codified in the 21 C.F.R. 556.286. The presence of this drug in this amount in the liver from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to review treatment records prior to offering an animal for slaughter for human food, to assure that drugs have been used only as directed and that appropriate withdrawal times have been observed. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act. [21 U.S.C. 342 (a)(4)].

You also adulterated penicillin G procaine and flunixin within the meaning of section 501(a)(5) [21 U.S.C. 351 (a)(5)] of the Act when you failed to use these drugs in conformance with their approved labeling. "Extra-label use", i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extra-label use of approved veterinary or human drugs must comply with sections 512(a)(4) [21 U.S.C. § 360(b)(a)(4)] and 512(a)(5) [21 U.S.C. § 360(b)(a)(5)] of the Act and 21 C.F.R. Part 530. Our investigation found that your extra-label use of penicillin G procaine and flunixin failed to comply with these requirements.

For example, you administered penicillin G procaine without following the dosage level and duration of treatment for cattle set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). In addition, you administered flunixin meglumine without following the route of administration for beef and dairy cattle set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extra-label use of these drugs resulted in illegal drug residues, in violation of 21 C.F.R. § 530.11(d). Because your extra-label use of these drugs was not in compliance with 21 C.F.R. Part 530, the drugs were unsafe under Section 512(a) [21 U.S.C. § 360b(a) and your use caused them to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)] of the Act.

The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.

Additionally, our investigation found you use a [redacted] calves that may be sold for bob veal. Please be aware that the use of this [redacted] to be sold for veal is contrary to its approved use. The label of this [redacted] advises the product is not to be used in calves that are to be processed for veal and that a withdrawal period has not been established for [redacted] in pre-ruminating calves. Since the Act does not permit the extralabel use [redacted] using the [redacted] calves intended for veal causes this medicated feed to be adulterated within the meaning of section 501(a)(6) [21 U.S.C. § 351(a)(6)] and unsafe under section 512(a)(2) [21 U.S.C. § 360(b)] of the Act.

You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violation and prevent its recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your written response should be sent to Anthony P. Costello; Compliance Officer, 1 Montvale Avenue, Stoneham, MA 02180. If you have any questions you can contact Mr. Costello at 781 596-7716.

Sincerely,

/S/

Gail T. Costello
District Director
New England District Office
 

cc:
Richard H. Hall
Co-Owner
Fairmont Farm Inc.
95 Lyle Young Drive
East Montpelier, VT 05651

Bonnie Hall
Co-Owner
Fairmont Farm Inc.
95 Lyle Young Drive
East Montpelier, VT 05651